MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-12 for XPER FLEX CARDIO PHYSIOMONITORING SYSTEM 860335 manufactured by Invivo Corporation.
[187934011]
Unable to confirm serial number. A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[187934012]
It was reported that, "during lpa stent case whilst taking pressures and doing a saturation run, initially on the doctors screen, pressure stopped displaying. The ecg was still running and then pressures went off. The doctor's screen froze and monitoring was lost for approximately ten minutes. There was no reported patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1051786-2020-00001 |
| MDR Report Key | 9700550 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-05 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT CORNING |
| Manufacturer Street | 12151 RESEARCH PARKWAY SUITE 200 |
| Manufacturer City | ORLANDO FL 32826 |
| Manufacturer Country | US |
| Manufacturer Postal | 32826 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPER FLEX CARDIO PHYSIOMONITORING SYSTEM |
| Generic Name | CARDIOVASCULAR MONITOR |
| Product Code | MWI |
| Date Received | 2020-02-12 |
| Model Number | 860335 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVIVO CORPORATION |
| Manufacturer Address | 12151 RESEARCH PARKWAY SUITE 200 ORLANDO FL 32826 US 32826 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |